EMIT is a multicenter, prospective, and noninterventional study conducted in Europe (NCT02950168). Several prespecified sub‐analyses will include stratification by country, by specialty of procedure (separate analysis for dentistry, ophthalmology, cardiothoracic and cardiac surgery, gastrointestinal), by under‐ or overdosing of edoxaban, by emergency vs planned procedure, by patients with single or multiple procedures, by type of VTE, and by type of AF (paroxysmal, persistent, or permanent). There have been no major protocol amendments since the first patient was enrolled.
This study was funded by Daiichi Sankyo, Inc. Assistance in editorial support for this manuscript was provided by AlphaBioCom, LLC (King of Prussia, Pennsylvania), and funded by Daiichi Sankyo, Inc. All authors materially participated in the design and/or drafting and editing of the paper and approved its final content. The Executive Committee is responsible for the study design, conduct, and supervision. The Steering Committee, in addition to supporting the Executive Committee in the overall oversight of the study, assures the study's implementation to optimize the quality of the data and study integrity. The steering Committee will make the decision to submit the paper for publication, and that the funding source has no role in this decision. See Appendix S1 (Supporting information) for the listing members of the Executive and Steering Committees, as well as the Principal Investigators.
The primary objective of this registry is to document the periprocedural management of patients receiving edoxaban and to collect data on safety and other outcomes in these patients. The primary safety outcome is the rate of major bleeding from 5 days prior to the procedure to 30 days postprocedure using the International Society of Thrombosis and Hemostasis (ISTH) definition14, 15 (Table S1). Other safety outcomes include the rates of CRNM bleeding, minor bleeding, all bleeding, and death from any cause. CRNM bleeding events are defined as overt bleeding that requires medical attention and that does not fulfill the criteria for a major bleeding event. A complete list of all procedures divided by European Heart Rhythm Association bleeding risk are listed in TableS2.
Secondary objectives include the evaluation of the periprocedural dosing of edoxaban and the efficacy outcome, defined as the composite of acute coronary syndrome, nonhemorrhagic stroke, transient ischemic attack (TIA), systemic embolic events (SEE), deep vein thrombosis (DVT), pulmonary embolism (PE), and cardiovascular (CV) mortality, and its individual components. The additional parameters recorded during the observational period are listed in Table S3.
The observation period of the study will start 5 days prior to the procedure and end 30 days postprocedure in all patients. The study design is shown in Figure 1. Since this is a noninterventional study, only data on routine clinical practice will be documented. In order to enhance the quality of data by capturing important details of the diagnostic and therapeutic procedures, and medication adherence/compliance, patients may will receive a memory aid (a booklet to complete) at enrollment into the study. This booklet is the basis of data capturing during the follow‐up phone call at 30 days.